Tokyo, May 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061689) titled 'A Retrospective Analysis of ADC Target Antigen Expression Profiles and Their Prognostic Significance in Endometrial Cancer' on May 26.
Study Type:
Observational
Primary Sponsor:
Institute - National Cancer Center Hospital East
Condition:
Condition - Endometrial cancer
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - This study aims to comprehensively analyze the expression of ADC target antigens, including HER2, TROP2, B7-H4, FRalpha, CDH6, HER3, and B7-H3, and their associations with hormone receptor status, including estrogen receptor and progesterone receptor expression, and PD-L1 expression.
Furthermore, this study aims to clarify the relationships between these biomarker expression profiles and clinicopathological factors, molecular characteristics, and prognosis, and to explore their potential utility as therapeutic targets and prognostic biomarkers for personalized medicine, as well as the potential for combination treatment strategies involving ADCs, hormone therapy, and immunotherapy.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1. Patients who are currently attending or have previously attended National Cancer Center Hospital East, National Cancer Center, Japan.
2. Patients for whom new comprehensive consent for the use of biobank specimens has been obtained.
3. Patients who were 18 years of age or older at the time of obtaining comprehensive consent.
4. Patients who were histologically diagnosed with stage III or IV endometrial cancer at our hospital between April 1, 2018 and December 31, 2025, and who received initial treatment, or patients with recurrent endometrial cancer.
5. Patients for whom formalin-fixed paraffin-embedded block specimens from surgical or biopsy samples are stored at our hospital.
Key exclusion criteria - 1. Cases with insufficient specimens available for the study.
2. Cases in which only cytological examination was performed and histological diagnosis was not confirmed.
3. Cases in which study information was disclosed through an opt-out process and the patient refused to participate in the study.
4. Other cases deemed inappropriate by the principal investigator.
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 19 Day
Date of IRB - 2026 Year 05 Month 19 Day
Anticipated trial start date - 2026 Year 05 Month 19 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070580
Disclaimer: Curated by HT Syndication.